(37 days)
The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- Volar plates are indicated for use with comminuted articular fractures, shearing . fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator;
- Locking volar plates are indicated for use with volar articular shearing fractures .
The LOCON™ VLS Distal Radius Plate System consists of plates, cortical screws, and cancellous screws. The design features of the plates and screw components are summarized below:
Plates
- Manufactured from stainless steel .
- Offered in two lengths: Standard and Long .
- Left and right configurations .
- Locking and non-locking screw holes in distal portion .
- Cortical screw holes located in proximal portion .
- Compression slot feature in proximal portion .
- K-wire holes in head and shaft t
- Cupped head with varying arch to accommodate patient's anatomy .
Cortical Screws - Manufactured from stainless steel .
- Available with 3.5mm diameter in lengths from 12mm- 20mm .
Cancellous Screws - Manufactured from stainless steel .
- Available in two designs: standard and locking .
- Standard screws are available with 2.7mm diameter in lengths from 12 26mm in 2mm . increments
- Locking screws are available with 2.7mm diameter in lengths from 14 26mm in 2mm t increments
The provided text describes a 510(k) premarket notification for a medical device, the LOCON™ VLS Distal Radius Plate. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria demonstrated through a clinical study with performance metrics.
Therefore, many of the requested elements regarding acceptance criteria and study details are not present in this document, as they are not typically part of a 510(k) for a Class II bone fixation plate. The document focuses on demonstrating that the new device is fundamentally similar in design, materials, and intended use to an existing device (LOCON-T® Distal Radial Plate System).
Here's an analysis of what information is and is not provided, based on your request:
1. A table of acceptance criteria and the reported device performance
- Not provided. This document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or mechanical performance) or reported device performance metrics in that context. The "acceptance" in a 510(k) substantial equivalence determination is that the new device is as safe and effective as the predicate, based on similar design and materials, and not inferior.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. There is no mention of a "test set" in the context of a clinical performance study. The substantial equivalence relies on comparison of design features, materials, and indications for use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This information would be relevant for a study where expert review establishes truth, typically for diagnostic or image-analysis devices. This document is for a bone fixation plate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This is relevant for AI or diagnostic imaging devices. The LOCON™ VLS Distal Radius Plate is a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is relevant for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the traditional sense. For a 510(k) of this nature, the "ground truth" or basis for safety and effectiveness is largely the established safety and effectiveness of the predicate device, supported by material characteristics (e.g., stainless steel properties) and design principles known for bone plates. No specific "ground truth" data from a study is presented here.
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
- Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission.
Summary of Information from the Document:
The LOCON™ VLS Distal Radius Plate received 510(k) clearance (K042358) based on demonstrating substantial equivalence to the LOCON-T® Distal Radial Plate System.
The "acceptance criteria" for this 510(k) submission were met by demonstrating that:
- The intended use of the LOCON™ VLS Distal Radius Plate is the same as the predicate device (fixation of unstable distal radial fractures).
- The device description (materials, design features like plate lengths, screw types, hole configurations) are similar. The plates are manufactured from stainless steel and consist of plates, cortical screws, and cancellous screws.
- The fundamental scientific technology has not changed relative to the predicate device.
The document states: "The safety and effectiveness of the LOCON™ VLS Distal Radius Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." However, the specific details of this "materials information, and analysis data" (e.g., mechanical testing results) are not included in this summary document.
The FDA's letter (Page 2-3 of the provided text) confirms that the device was found "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.